UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023006 |
|---|---|
| Receipt number | R000026517 |
| Scientific Title | Usefullness of infliximab as a second tumor necrosis factor inhibitor in patients with rheumatoid arthritis with inadequate response to tumor necrosis factor inhibitor |
| Date of disclosure of the study information | 2016/07/15 |
| Last modified on | 2019/07/07 09:29:42 |
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Basic information
Public title
Usefullness of infliximab as a second tumor necrosis factor inhibitor in patients with rheumatoid arthritis with inadequate response to tumor necrosis factor inhibitor
Acronym
IFX-2nd
Scientific Title
Usefullness of infliximab as a second tumor necrosis factor inhibitor in patients with rheumatoid arthritis with inadequate response to tumor necrosis factor inhibitor
Scientific Title:Acronym
IFX-2nd
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Serum tumor necrosis factor (TNF) level was reported to be relatively higher in the patients with rheumatoid arthritis (RA) especially with inadequate response to first TNF inhibitor (TNFi). For those RA patients with inadequate response to TNFi it was reported that increasing dose of TNFi was required in order to reduce disease activity of RA. Because increasing dose or shorter interval of administration was approved for the use of infliximab (IFX), IFX seems ideal for the purpose of use in such cases. In this study we investigate the better efficacy of increasing dose of IFX than ordinary dose from the start in patients with RA with inadequate response to TNFi except IFX.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Evaluation of disease activity score 28-CRP (DAS28-CRP) at 30 weeks
Key secondary outcomes
1) Evaluation of structural damage by modified total Sharp score at 54 weeks
2) Evaluation of synovitis by ultrasound at 54 weeks
3) Evaluation of blood test at 54 weeks
4) Evaluation of modified Health Assessment Questionnaire at 54 weeks
5) Adverse reaction at 54 weeks
6) Evaluation of DAS28-CRP at 30 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administrated with 3mg/kg of IFX
Interventions/Control_2
administrated with 10mg/kg of IFX
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Out-patients who is planned to receive IFX with active moderate-to-severe RA with inadequate response to adalimumab, etanercept, golimumab or certolizumab pegol
2) The patients who administrated with methotrexate
3) Patients must have taken stable dose of NSAID, glucocorticoid, or conventional synthetic disease modifying anti rheumatic drugs
4) Aged 20 years or older and less than 85 years old
5) The patients who provided their informed consent to participate in the study
Key exclusion criteria
1) The patients with inadequate response to IFX after 6-weekloading administration
2) The patients with arthritic condition other than Ra
3) The patients who is planned to undergo surgery
4) Patients with allergy to IFX
5) Patients who is pregnant or lactate
6)patients who have received IFX administration
7) Those who are not approved to be eligible to this study by corresponding researcher or co-researchers
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Inui |
Organization
Osaka City University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
545-8585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka545-8585, Japan
TEL
06-6645-3851
inuken@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Inui |
Organization
Osaka City University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
545-8585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka545-8585, Japan
TEL
06-6645-3851
Homepage URL
inuken@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University Hospital Certified Review Board
Address
1-2-7-601 Asahi-machi, Abeno-ku, Osaka
Tel
06-6645-3456
ethics@med.osaka-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
1
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 04 | Day |
Last modified on
| 2019 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026517
